Infection of Intravenous CatheterPhase 4NCT01794767
Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children
A Phase 4 study testing 0,9% NaCl flush and Heparin 50U/ml in people with Infection of Intravenous Catheter and Phlebitis, run by University of Florence at 1 site in Italy.
Trial summary
The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 U / ml flush, in children from 2 years to 14 years. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Infection of Intravenous Catheter, Phlebitis, Extravasation of Diagnostic and Therapeutic Materials
- What is being tested?
- 0,9% NaCl flush and Heparin 50U/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Aug 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 2 years and 14 years old
- Medical prescription of intravenous antibiotic therapy for at least 2 doses on the day
- Presence of informed consent to participate to the study provided by the parents
- No known hypersensitivity to heparin
- No known hypersensitivity to the patch fixing materials (polyurethane and / or glue)
- Absence of diseases buoyancy coagulation (haemophilias and / or thrombophilias)
- No antecedents trombopenie dued to the use of any type of heparin or a pentosan polysulfate
- No existing treatment based on corticosteroids and / or anti-inflammatory
Who cannot join
- age outside the range 2 - 14 years
- children for which there is no prescription of intravenous antibiotic therapy for at least 2 times a day
- children for which the parents have not consented to the study
- children with known hypersensitivity to heparin
- children with known hypersensitivity to the patch fixing materials (polyurethane and / or adhesive)
- children with disease-causing buoyancy coagulation (Hemophilia and / or thrombophilia)
- children with antecedents of trombopenie occurring by the use of any type of heparin or of a pentosan polyphosphate
- children in treatment with corticosteroids and / or anti-inflammatory
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge catheters Will be included in the study.The study will assess in particular:
- the difference of permanence in situ of the device
- the difference in incidence of complications (in detail: obstruction, phlebitis, thrombocytopenia, systemic anticoagulation)
- the difference in costs between use of saline normal saline 0.9% NaCl solution and heparinized 50 U / ml.
- Conditions
- Infection of Intravenous Catheter, Phlebitis, Extravasation of Diagnostic and Therapeutic Materials
- Being tested
- 0,9% NaCl flush, Heparin 50U/ml
- Keywords
- peripheral venous catheter, children.
- Medical subject headings
- Phlebitis, Extravasation of Diagnostic and Therapeutic Materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0,9% NaCl flushDrug
Also called Normal Saline
Normal Saline solution
Heparin 50U/mlDrug
Also called Heparin solution 50 U/ml, Epsodilave
Heparin solution
| Study group | Role | What they receive |
|---|---|---|
| 0,9% NaCl flush | Active comparator | for children enrolled in this group, the nurse will perform the flushing of peripheral venous catheter using flush-solution as a bolus with saline 0.9% NaCl in the amount (ml) needed to fill the entire circuit of the catheter. The flushing will be performed routinely at the end of each fleboclisis Receives: Drug: 0,9% NaCl flush |
| Heparin 50U/ml | Experimental | for children enrolled in this group, the nurse will perform the washing of peripheral venous catheter using flush-solution as a bolus with heparin 50U/ml in the amount (ml) needed to fill the entire circuit of the catheter. The washing will be performed routinely at the end of each fleboclis Receives: Drug: Heparin 50U/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average length of stay on site of the catheter measured in hours
Measured: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 dayse
Secondary outcomes (2)
Incidence of complications extimated overall and by type of complication
Measured: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days
Average cost for the maintenance of the catheter of each subject (pro day and in total)
Measured: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2016 (estimated)
Why it stopped: difficult recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection of Intravenous CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Festini, University of Florence
- Investigators
- Filippo Festini, RN, BSN, MSN, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794767
- Sponsor's protocol ID
- Heparin2012
- Status last verified
- Oct 2015
- First submitted
- 29 Jan 2013
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children
- ClinicalTrials.gov ID
- NCT01794767
- Acronym / sponsor ID
- Heparin2012
- Conditions
- Infection of Intravenous Catheter, Phlebitis, Extravasation of Diagnostic and Therapeutic Materials
- Keywords
- peripheral venous catheter, children.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: difficult recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge catheters Will be included in the study.The study will assess in particular:
- the difference of permanence in situ of the device
- the difference in incidence of complications (in detail: obstruction, phlebitis, thrombocytopenia, systemic anticoagulation)
- the difference in costs between use of saline normal saline 0.9% NaCl solution and heparinized 50 U / ml.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0,9% NaCl flush | Active comparator | Drug: 0,9% NaCl flushfor children enrolled in this group, the nurse will perform the flushing of peripheral venous catheter using flush-solution as a bolus with saline 0.9% NaCl in the amount (ml) needed to fill the entire circuit of the catheter. The flushing will be performed routinely at the end of each fleboclisis |
| Heparin 50U/ml | Experimental | Drug: Heparin 50U/mlfor children enrolled in this group, the nurse will perform the washing of peripheral venous catheter using flush-solution as a bolus with heparin 50U/ml in the amount (ml) needed to fill the entire circuit of the catheter. The washing will be performed routinely at the end of each fleboclis |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age between 2 years and 14 years old
- Medical prescription of intravenous antibiotic therapy for at least 2 doses on the day
- Presence of informed consent to participate to the study provided by the parents
- No known hypersensitivity to heparin
- No known hypersensitivity to the patch fixing materials (polyurethane and / or glue)
Key exclusion criteria (8 listed)
- age outside the range 2 - 14 years
- children for which there is no prescription of intravenous antibiotic therapy for at least 2 times a day
- children for which the parents have not consented to the study
- children with known hypersensitivity to heparin
- children with known hypersensitivity to the patch fixing materials (polyurethane and / or adhesive)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0,9% NaCl flushAlso: Normal SalineNormal Saline solution | Drug | 0,9% NaCl flush |
| Heparin 50U/mlAlso: Heparin solution 50 U/ml, EpsodilaveHeparin solution | Drug | Heparin 50U/ml |
Primary outcome
Average length of stay on site of the catheter measured in hours
Time frame: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 dayse
2 secondary outcomes
Incidence of complications extimated overall and by type of complication
Time frame: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days
Average cost for the maintenance of the catheter of each subject (pro day and in total)
Time frame: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filippo Festini, RN, BSN, MSN principal investigator
University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0,9% NaCl flush and Heparin 50U/ml in people with Infection of Intravenous Catheter and Phlebitis, run by University of Florence at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average length of stay on site of the catheter measured in hours (time frame: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 dayse). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.